"Speaking of Vitiligo..."

Hi everyone, I have received several questions about the RSVP study sponsored by AVITA Medical, which is evaluating if pigment returns to white spots of patients with vitiligo using the RECELL System. We sent a notice earlier about the study to those who have signed up for our newsletter – remember that this is the best way to hear about new studies when we start recruiting, you can sign up for the newsletter here.

To provide a little more detail, the RSVP study is specifically for those who have treatment-resistant vitiligo that is STABLE, or not changing for at least 1 year. The process being tested is to transplant pigment cells from one part of the body without vitiligo to another part that is affected by vitiligo. Previous studies have shown that this general approach can be very effective if the vitiligo is stable as described above. It doesn’t work well if the vitiligo is not stable.

You can read more about the procedure, called melanocyte keratinocyte transplant procedure (MKTP) in a previous blog post. We have performed this procedure here at UMass for over 6 years, and it is also available at 1-2 other locations across the country, but the RSVP trial is testing whether a simpler approach using the RECELL System may be able to make the procedure available at more locations, by more dermatologists. Dr. Bassel Mahmoud is on our faculty here at UMass and has a lot of experience with MKTP - he was highlighted in this article by the Boston Globe recently, and he is the principal investigator of the trial here at UMass.

Briefly, the RECELL system turns a normally pigmented piece of your own skin into cells that can be “sprayed on” to vitiligo spots that had been previously prepared by removing the top layer of skin, like how we normally do MKTP. If you’re interested, the details of the study are outlined below, and to see if you may qualify, you can follow the link to take a short survey to provide some details and let the team know of your interest. The study is offering compensation and travel support. There are multiple centers participating in the study, and the survey will help to find a location near you where you can participate if you qualify.

SEE IF YOU QUALIFY 

What is the RSVP study?

The RSVP Study is evaluating the RECELL System, an investigational device, for treating patients with stable vitiligo. The study is being conducted at 15 locations across the United States, including UMass Chan Medical School.

Why are clinical trials for vitiligo needed?

There are currently no FDA approved treatments for vitiligo. Clinical trials are important for discovering new treatments and determining how well they work and if they are safe. Clinical trials also allow patients to try some of the latest therapies for vitiligo.

What is involved in participating in the RSVP study?

The RSVP study is a clinical trial that involves a one-time surgical procedure. Patients will be evaluated by the study doctor and have the study explained to them. If a patient agrees to participate, their vitiligo and medical history will be reviewed to determine if they qualify for treatment. Those who qualify will be scheduled for the one time treatment and together with their study doctor decide which vitiligo areas to treat (if more than one).  After treatment, patients will be provided with a hand-held light therapy device to use at home on the study areas for 3-6 months.  Patients will come back to the clinic for check-ups every couple of months for 1 year. The study doctor will check on their vitiligo, take measurements and photos, and make sure that they are not having any problems at these visits.  At the end of the study, patients will be offered an additional treatment with the RECELL System for any remaining depigmentation in the study areas.    

What type of patients are good candidates for the RSVP study?

To qualify, patients must be at least 18 years old, and their vitiligo must be stable for at least one year (no new areas nor increase in size of current areas). Patients also need to have tried and not satisfactorily responded to both topical treatment and phototherapy.

How does the RECELL System work and what happens during the procedure?

A small sample of the patient’s own healthy pigmented skin is taken and used in the RECELL System to prepare a liquid cell mixture of healthy skin cells, called Spray-On Skin™ Cells. The area with vitiligo is prepared with a laser to remove the very top layer of skin before the  patient’s Spray-On Skin™ Cells are applied. Special bandages will be placed over the treatment area for 1 week while the area is healing.

How long will I have to participate?

Patients will participate for 52 weeks (1 year) and come to clinic a total of 8 times during that period. Compensation and travel support is available.

Who can help me decide if participating in the RSVP study is right for me?

Patients should talk to their study doctor and personal doctor or dermatologist to help decide if participating in the RSVP study is right for them. The study doctor can explain what is involved in participating and the potential risks. Patients can also talk to trusted family members or friends to help decide if the study is right for them.

Where can I get more information about the study? 

For more information about the RSVP study, including finding out of you qualify, visit https://vitiligorsvpstudy.mmgct.com